A Phase 2A Open-label Trial to Assess the Safety of ZIMURA™ (Anti-C5) Administered in Combination With LUCENTIS® 0.5 mg in Treatment Naive Subjects With Neovascular Age Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 28
- 主要终点
- Ophthalmic Adverse Events
研究概览
简要总结
To assess the safety of intravitreal Zimura™ (complement factor C5 inhibitor) administered in combination with Lucentis® 0.5 mg in treatment naïve subjects with neovascular age related macular degeneration (NVAMD)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active subfoveal NVAMD
排除标准
- •History or evidence of severe cardiac disease
- •Any major surgical procedure within one month of trial entry
- •Subjects with a clinically significant laboratory value
- •Any treatment with an investigational agent in the past 60 days for any condition
- •Women who are pregnant or nursing
- •Known serious allergies to the fluorescein dye used in angiography, povidone iodine, to the components of the ranibizumab formulation, or to the components of the Zimura formulation
- •Any prior treatment for AMD other than oral supplements of vitamins and minerals
研究组 & 干预措施
Cohort 1
Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
干预措施: Avacincaptad Pegol (Drug)
Cohort 1
Avacincaptad Pegol dosage 1 + Lucentis 0.5 mg
干预措施: Lucentis (Drug)
Cohort 2
Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
干预措施: Avacincaptad Pegol (Drug)
Cohort 2
Avacincaptad Pegol dosage 2 + Lucentis 0.5 mg
干预措施: Lucentis (Drug)
Cohort 3
Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
干预措施: Avacincaptad Pegol (Drug)
Cohort 3
Avacincaptad Pegol dosage 3 + Lucentis 0.5 mg
干预措施: Lucentis (Drug)
Cohort 4
Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg
干预措施: Avacincaptad Pegol (Drug)
Cohort 4
Avacincaptad Pegol dosage 4 + Lucentis 0.5 mg
干预措施: Lucentis (Drug)
结局指标
主要结局
Ophthalmic Adverse Events
时间窗: 6 months
Number of participants with ophthalmic Adverse Events (with calculated percentage)
Systemic Adverse Events
时间窗: 6 months
Number of Participants with systemic treatment-emergent Adverse Events (with calculated percentage)
次要结局
未报告次要终点